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BD Connecta™ Plus 3 Way Stopcock with 10 cm Extension Line

BD Connecta™ Plus 3 Way Stopcock with 10 cm Extension Line

Becton Dickinson

Medical device – IV extension set / stopcock
  • CE Marked Class IIa medical device under the EU Medical Devices Directive 93/42/EEC, Annex IX Rule 2, with notified body BSI (2797).
  • CE certificate for BD Connecta™ stopcock with extension tube range (including REF 394995) issued by BSI, as documented in the BD Technical Data Sheet and Declaration of Conformity.
  • Legal manufacturer BD Infusion Therapy AB, Helsingborg, Sweden, certified to ISO 13485 (certificate MD 597883 or successors).
  • Manufacturing site BD Infusion Therapy Systems S.A. de C.V., Nogales, Sonora, Mexico, certified to ISO 13485 (certificate FM 673986 or successors).
  • Device classification confirmed in Declaration of Conformity for BD Connecta™ stopcock products (including 394995) as Class IIa under Annex IX, Rule 2 of the MDD.
  • Sterilisation by radiation validated according to relevant EN ISO standards for radiation sterilisation of healthcare products (e.g., EN ISO 11137 series).
  • Biocompatibility evaluated according to ISO 10993 series for medical devices with blood Contacting components in infusion systems.
  • Luer Lock and connector design compliant with applicable ISO standards for conical and Luer fittings used in infusion and pressure monitoring systems.
  • Materials statement in BD literature and catalogues confirms that DEHP and natural rubber latex are not part of the material formulation for BD Connecta™ stopcocks and extension sets.
  • Product included in BD Connecta™ stopcocks and extension sets listings within official BD catalogues and technical data sheets used in EMEA and other regions.
3-way stopcock with extension line for infusion therapy and haemodynamic pressure monitoring

Description

The BD Connecta™ Plus 3-Way Stopcock with 10 cm Extension Line (REF 394995) is a sterile, single-use, latex-free IV accessory designed for infusion therapy and haemodynamic pressure monitoring. It consists of a 3-way stopcock with colour-coded pegs and a white tap, pre-attached to a 10 cm macrobore extension line in DEHP-free PVC. The set provides high flow capacity with low priming volume and features a Luer-lock connection, enabling secure integration into IV lines and pressure monitoring systems. The device is CE-marked (Class IIa), radiation-sterilised and supplied in boxes of 50 units.

Bnefits

  • Designed for infusion therapy and haemodynamic pressure monitoring, allowing connection of multiple lines or devices via a single 3-way stopcock.
  • 3-way stopcock with colour-coded pegs and tactile on/off snaps provides clear visual and tactile feedback of open/closed positions, supporting accurate and safe fluid routing.
  • Integrated 10 cm extension line reduces the need for separate connectors and tubing pieces, simplifying set-up and minimising potential leak points.
  • High flow capacity with low priming volume (approx. 0.78 mL) helps support efficient infusion and pressure transmission while reducing dead space and medication waste.
  • Macrobore PVC tubing and stopcock design are lipid resistant and suitable for use with a wide range of IV fluids, including lipid-containing solutions, for the recommended duration.
  • Extension line and stopcock materials are DEHP-free and not made with natural rubber latex, reducing exposure to these substances for patients and healthcare workers.
  • Fixed Luer-lock connection provides secure attachment to compatible IV devices and transducer sets, helping to reduce the risk of disconnection and leakage during use.
  • Single-use, radiation-sterilised device supports infection prevention and reduces the risk of cross-contamination when used according to aseptic technique.
  • Compact 10 cm length is well suited for proximal use at the catheter or transducer site, helping to maintain accurate pressure transmission and reducing line clutter.
  • CE-marked Class IIa device manufactured under ISO 13485-certified quality systems, supporting consistent performance and regulatory compliance.

Indications

  • Use as part of an intravenous infusion system for administering fluids and medications where a 3-way stopcock with extension line is clinically indicated.
  • Haemodynamic pressure monitoring (e.g., arterial or central venous pressure measurement) in conjunction with compatible transducers and pressure monitoring equipment.
  • Infusion therapy requiring connection of multiple lines or devices (e.g., additional infusion line or sampling line) through a 3-way stopcock.
  • Situations requiring a short (10 cm) proximal extension between vascular access device and the main IV line or transducer set for easier access and manipulation.
  • Use in hospital, theatre, critical care, emergency, and other acute or chronic care settings by trained healthcare professionals.

Composition

  • Stopcock housing: Polycarbonate.
  • Stopcock tap/handle: Polyethylene.
  • Extension tube: Polyvinyl chloride (PVC), DEHP-free.
  • Nut (Luer-lock component): Polycarbonate.
  • Plug: Polypropylene.
  • Protection cap(s): Polyethylene.
  • Master batch (white colour): Polymer colour concentrate compatible with medical-grade plastics.
  • Silicone lubricant: Polydimethylsiloxane (liquid silicone) applied to appropriate components to ensure smooth tap operation.
  • Latex status: Not made with natural rubber latex.
  • Plasticiser status: DEHP is not part of the material formulation for the extension line.

Formulation

  • BD catalog number: 394995 (BD Connecta™ Plus 3-way stopcock with 10 cm extension line, white).
  • Configuration: 3-way stopcock with pre-attached extension tube.
  • Stopcock type: BD Connecta™ Plus 3-way stopcock with colour-coded pegs.
  • Tap colour: White (with colour coding pegs on the body).
  • Extension tubing length: 10 cm (nominal).
  • Total set length: Approximately 16 cm.
  • Luer-lock type: Fixed Luer-lock connection.
  • Number of stopcocks: 1 per set.
  • Priming (dead space) volume: Approx. 0.78 mL (nominal low filling/priming volume).
  • Maximum working pressure: Up to approximately 5 bar (≤ 5 bar) as specified for the macrobore extension set configuration.
  • Number of backcheck valves: 0.
  • Number of anti-syphon valves: 0.
  • Number of needle-free connectors: 0.
  • Number of filters: 0.
  • Number of clamps: 0.
  • Tubing material: PVC (macrobore), DEHP-free and latex-free.
  • Sterilisation: Radiation-sterilised single-use device.
  • Intended use category: Infusion therapy and haemodynamic pressure monitoring (Class IIa, sterile, single-use).

Packaging

  • Individual unit packaging: Each BD Connecta™ Plus 3-way stopcock with 10 cm extension line is supplied sterile in an individual blister or peel-open pack with product identification, lot number and expiry date.
  • Box (shelf pack) quantity: 50 units per box (REF 394995), as listed by BD and distributors.
  • Shipping case quantity: 250 units per shipping case (5 boxes of 50).
  • GTIN – Each: 00382903949953 (1 unit).
  • GTIN – Shelf pack (box of 50): 30382903949954.
  • GTIN – Case (250 units): 50382903949958.
  • Packaging unit description (e.g., Megro): VE = 50 pieces (box) / UK = 250 pieces (outer carton).
  • Labelling includes CE mark (BSI 2797), BD branding, product name, reference/lot number, sterile symbol, single-use symbol and storage/handling symbols.

Usage

  • Use only by trained healthcare professionals familiar with IV infusion systems and haemodynamic pressure monitoring devices.
  • Before use, inspect the individual sterile package; do not use if the packaging is damaged, opened or if the expiry date has passed.
  • Using aseptic technique, open the sterile pack and remove the device, taking care not to contaminate the Luer-lock connectors, stopcock ports or extension line.
  • Connect the extension line Luer-lock to the appropriate IV catheter, transducer set or other compatible device by engaging the Luer taper and tightening the Luer-lock nut securely.
  • Connect the remaining stopcock ports to compatible IV lines, syringes or devices as required, ensuring that all Luer connections are fully tightened to prevent leaks.
  • Use the stopcock tap and colour-coded pegs to select the desired flow path; tactile on/off snaps and visible markings help confirm whether each port is open or closed.
  • Prime the extension line and stopcock with the appropriate fluid, removing air in accordance with local protocols and manufacturer instructions for associated infusion/monitoring equipment.
  • During use, regularly verify that all connections remain secure, that the selected flow path corresponds to the intended therapy or monitoring configuration, and that there are no leaks or air bubbles.
  • Do not exceed the specified maximum working pressure when used with pressure infusers or other pressurised systems.
  • At the end of therapy or when line changes are required, clamp or stop fluid flow according to institutional protocol, disconnect the device carefully and dispose of it as clinical waste in accordance with local regulations.
  • Do not attempt to clean, reprocess or resterilise. The device is intended for single use only.
  • Refer to the BD Connecta™ Stopcock with Extension Tube Technical Data Sheet, Declaration of Conformity and any relevant electronic Instructions for Use (eIFUs) for full instructions, warnings and precautions.

Contraindications

  • Do not use if the sterile barrier packaging is damaged, opened or shows signs of contamination.
  • Do not reuse, reprocess or resterilise; the device is intended for single use only.
  • Do not use with fluids or drugs known to be incompatible with PVC or other component materials; consult compatibility data for non-standard or solvent-containing solutions.
  • Do not exceed the specified maximum working pressure; use only with pressure infusers and monitoring systems within the device’s pressure rating.
  • Do not use if any component (stopcock, tubing or connectors) appears cracked, discoloured, occluded or otherwise damaged.
  • Do not use in patients with known hypersensitivity to any of the device materials if such hypersensitivity is clinically relevant, although the product is latex-free and DEHP-free.
  • Do not use as an implantable or long-term indwelling device.
  • Follow all contraindications, warnings and precautions listed in the BD Connecta™ Stopcock with Extension Tube Technical Data Sheet, Declaration of Conformity and local vascular access/infusion guidelines.

Adverse Effects

  • Potential for local or systemic infection if aseptic technique is not maintained during installation, use or removal, or if the device is left in place longer than recommended line-change intervals.
  • Risk of air embolism if the system is not correctly primed or if connections are loosened or disconnected without proper clamping or line management.
  • Extravasation or infiltration of infusate at the vascular access site if the upstream catheter is malpositioned, dislodged or occluded.
  • Inaccurate haemodynamic pressure readings if air bubbles, kinks, occlusions or inappropriate positioning of the stopcock and extension line occur.
  • Fluid leakage and under- or over-infusion if Luer connections are not properly tightened or if the stopcock tap is mispositioned.
  • Very rare risk of hypersensitivity or allergic reactions to device materials in susceptible individuals, although the product is not made with natural rubber latex and is DEHP-free.
  • Potential line-related complications such as thrombophlebitis or catheter-related bloodstream infection associated with the overall IV system rather than the stopcock itself, particularly if standard vascular access care bundles are not followed.

Storage Conditions

  • Store in the original, unopened packaging until point of use to maintain sterility and protect from contamination.
  • Keep in a clean, dry environment at normal room temperature; avoid extreme temperatures and large temperature fluctuations.
  • Do not expose the product to excessive humidity or direct sunlight for prolonged periods, as indicated in manufacturer literature.
  • Avoid crushing, bending or otherwise damaging cartons or individual sterile packs.
  • Do not use after the expiry date printed on the packaging.
  • Store in accordance with local hospital or facility policies for sterile disposable medical devices.

Duration

Single-use IV accessory intended to remain in the line for the duration of a single infusion or monitoring setup, according to local protocols for IV set and line-change intervals. The device is not intended for reuse or long-term indwelling use beyond the life of the associated infusion/monitoring set.

Onset

Provides immediate functionality for fluid routing and haemodynamic pressure transmission once connected, primed and correctly positioned within the IV or monitoring system. Clinical onset of drug or fluid effects depends on the infused solution and patient factors, not on the stopcock itself.

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